Engineer IV, Manufacturing Research

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 116,600 - 177,800; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision coverage

Paid time off and holidays

Job summary

Meso Scale Diagnostics LLC (MSD) is seeking an experienced leader to drive R&D of high-volume manufacturing methods for diagnostic consumables. You will guide scalable design, develop prototypes, and collaborate with internal teams to scale processes from research to production.

Ideal candidates have a strong background in high-throughput manufacturing and regulatory-compliance experience, with a track record in biologics production and cGMP environments.

Qualifications

• Bachelor’s degree in biology, chemistry, biotech, engineering or related field.
• Master’s degree in a similar field preferred.
• Minimum 10 years in high-throughput plastic manufacturing.
• Minimum 5 years manufacturing biological products preferred.
• Experience with cGMP and/or ISO certifications preferred.

Responsibilities

• Lead a multidisciplinary R&D team for high-volume consumables manufacturing.
• Guide scalable, high-quality consumable design processes.
• Develop prototypes for consumable manufacturing and inspection.
• Make key technical decisions during R&D activities.
• Hands-on work in active experimental programs.
• Prepare designs and technical reports for projects.
• Create/update manufacturing and project documents and procedures.
• Collaborate with Quality to meet guidelines.
• Ensure compliance with regulatory standards.

Skills

Roll-to-Roll processing

Sheet-to-sheet processing

Plastic film processing

Bonding techniques

Forming techniques

Coating techniques

Biological handling

Project leadership

Regulatory compliance

Analytical thinking

Education

Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering

Master’s degree preferred

Tools

cGMP

ISO certification

Job description

POSITION SUMMARY

This position will play a critical role in supporting high-impact research initiatives at MSD related to the research and development of manufacturing methods for clinical consumables. This role will work with a team of engineers and scientists to design and evaluate novel and high throughput manufacturing techniques for next generation diagnostic consumables, and eventually work closely with an internal automation team to scale up to high volume production. The role involves close collaboration with both internal departments and external partners to drive innovation and achieve research objectives.

DUTIES AND RESPONSIBILITIES

• Lead a multidisciplinary team in the research and development of new high-volume manufacturing methods for consumables.
• Guide the consumable design process to be highly scalable and high quality.
• Develop and prototype systems for consumable manufacturing and inspection.
• Make and guide key technical decisions throughout research and development activities.
• Perform hands-on work as part of active experimental programs.
• Prepare and present project designs and technical reports as needed.
• Create and/or update manufacturing and project documents and procedures.
• Work with Quality to ensure products are manufactured and/or assembled according to quality guidelines.
• Ensure compliance with relevant regulatory standards.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in Biology, Chemistry, Biotechnology, Engineering or related field is required.
• Master’s degree in a similar field is preferred.
• Minimum 10 years of experience in high throughput plastic manufacturing.
• Minimum 5 years of experience manufacturing biological products preferred.
• Experience with cGMP and/or ISO certification is preferred.
• Desirable skill sets may include but are not limited to the following:
  • Manufacturing immunoassays and/or reagents.
  • In-vitro diagnostic devices and consumables.

KNOWLEDGE, SKILLS AND ABILITIES

• Deep experience with several of the following manufacturing methods at scale:
  • Roll-to-Roll processing and converting
  • Sheet-to-sheet or sheets-on-shuttle processing
  • Plastic film and metal foil processing techniques:
    • Bonding (thermal, ultrasonic, laser, adhesive, solvent)
    • Forming (stamping, thermal embossing, drawing, ultrasonic)
    • Cutting (laser, knife)
  • Liquid integration (Blister packs design and formation or similar)
    • Plastic vapor barriers (materials and methods)
    • Liquid addition and sealing
    • Lyophilized reagent addition and sealing
  • Coating techniques such as:
    • Liquid and ink: Slot Die, micro gravure, Meyer rod, ink jet, spray coating, screen printing, and dip coating
    • Vacuum based: sputtering and evaporation
• Biological handling and coating
• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
• Ability to lead and guide staff to meet department goals.
• Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem solving.
• Excellent oral, written communication and interpersonal skills.
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding research environment with changing priorities.

PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT

This position will operate in the following areas of the organization:

• Traditional office environment
• Chemistry and BSL-1/BSL-2 lab environment
• Engineering prototype and production space

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company’s overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees’ well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO STATEMENT

MSD is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here. MSD uses E-Verify to validate the work eligibility of candidates.